← FDA DRUG APPROVALS

FDA NDA · NDA022425

MULTAQ

dronedarone

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA022425
TYPE
NDA
ORIGINAL APPROVAL
2009-07-01
LATEST ACTION
2023-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MULTAQ · ReferencePrescription
DRONEDARONE HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL

Approval history

2023-10-23Labeling · Supplement 28 · standard — Letter ↗AP
2023-10-23Efficacy · Supplement 30 · standard — Letter ↗AP
2020-11-16Labeling · Supplement 29 · standard — Letter ↗AP
2016-02-12REMS · Supplement 27 — Letter ↗AP
2014-03-31Labeling · Supplement 25 · standard — Letter ↗AP
2014-03-19Manufacturing (CMC) · Supplement 26 · priorityAP
2014-03-19REMS · Supplement 24AP
2014-03-19REMS · Supplement 22 — Letter ↗AP
2014-01-30Labeling · Supplement 23 · standard — Letter ↗AP
2013-03-27Labeling · Supplement 21 · standard — Letter ↗AP
2012-09-07Labeling · Supplement 18 · unknown — Label ↗AP
2012-09-07Labeling · Supplement 16 · unknown — Letter ↗AP
2012-09-07REMS · Supplement 17 — Label ↗AP
2012-06-13REMS · Supplement 14 — Label ↗AP
2012-01-25Labeling · Supplement 2 · unknown — Label ↗AP
2011-12-19Labeling · Supplement 13 · unknown — Label ↗AP
2011-08-22Labeling · Supplement 12 · unknown — Label ↗AP
2011-08-05REMS · Supplement 6 — Letter ↗AP
2011-06-21Labeling · Supplement 10 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 7 · unknown — Letter ↗AP
2011-02-11Labeling · Supplement 5 · unknown — Letter ↗AP
2011-02-11Labeling · Supplement 1 · standard — Label ↗AP
2011-01-31Labeling · Supplement 4 · unknown — Label ↗AP
2009-07-01Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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